Quantitative Benefit-Risk Assessment for the New PSUR 2015

Topics

• Concepts behind quantitative BRA and why quantification is necessary
• Requirements of the New EU legislation (GVP) for the New PSUR (Periodic Safety Update Reports)
• The role of quantitative models in BRA and regulatory expectations including the current opinion of the European working groups
• The process for undertaking BRA and the evidence and data requirements
• Principles and practice of statistical BRA including the advantages and disadvantages of the principal methods
• Methodological options available and their pro’s and con’s
• Case studies and exercises
• How to implement/optimise BRA for the new PSUR in your company and what other companies are implementing